FDA Cleared vs. Medical Grade Materials vs. FDA Approved

FDA Cleared vs. Medical Grade Materials vs. FDA Approved

Mar 16th 2018

Browsing Amazon, Ebay or other online retailers you will frequently see the claim that a cup was made with medical grade silicone.

It is not surprising that we frequently get the question: Is the MeLuna USA cup made with medical grade material?

Today I would like to take some time to discuss how much (or little) value there is in the medical grade material claims of some manufacturers as well as how much is involved in getting a cup FDA cleared. By the way there are no FDA 'approved' cups. The FDA does not approve cups. If you see this term in any kind of cup advertising, it should immeditatley raise a red flag.

First things first though: ALL components of the MeLuna USA cups are medical grade materials. In fact the materials, including the colorants, were registered with the FDA and used in other medical device applications long before we started applying for FDA clearance and producing MeLuna USA cups made with these components.

It is not likely that one could achieve FDA clearance without using these registered medical grade materials.

So why the emphasis on medical grade materials in online ads for cheap, unregistered cups?

It's easy to use the term to advertise with and put consumers at ease about a product that is NOT FDA cleared and may contain other components that are not medical grade as well as be manufactured in conditions not meeting medical device manufacturing standards... in a way it's misleading and taking advantage of consumers.

Think of it this way: I could make you a pie and use organic apples in it. I could claim the organic apples when I advertise for my pies. But you still would have no idea what other ingredients are in the pie or if the pie was made in a clean kitchen, etc. Medical grade silicone is just one component of a cup and no indication of the quality or safety of the finished product.

FDA clearance goes much beyond medical grade materials. It also means the cup is manufactured in an FDA registered facility as well as imported by an FDA registered facility. FDA registered facilities are inspected by the FDA on a regular basis to ensure good manufacturing practices are being observed and quality control systems are in place.
Both the US distribution facility in Texas as well as the state-of-the art manufacturing facility in Germany have been thouroughly inspected by the FDA. An FDA agent is on site for four days to observe during each inspection.

There is no oversight at all over factories in Asia or elsewhere that distribute cups with just the medical grade silicone claim.

We strongly suggest you do not fall for these claims and instead choose a cup with a proven safety standard. Maybe MeLuna is not the cup that appeals to you the most? There are many quality cups out there with FDA clearance to choose from. If you don't choose MeLuna, please do consider choosing another cup of equal quality. If in doubt you can actually do a search for menstrual cups on the FDA website to see if a cup brand you are interested in is FDA registered.*

By the way if you ever see the term 'FDA Approved' on a Menstrual Cup, it should raise a red flag. The FDA does not approve menstrual cups. A menstrual cup, after having gone through the lengthy clearance process, is considered FDA cleared. The product itself is FDA registered and the facility is FDA registered. But anybody advertising with FDA Approved cups shows that they actually don't even have an idea how the FDA Medical Device process works. 

...and if you do choose a MeLuna USA cup: THANK YOU SO MUCH! We put a lot of work into bringing these cups to you and take pride in providing you with an outstanding, quality, safe product!

Karin

CEO MeLuna USA

*If you live in a different country, your country may have their own health agency that you can check.